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Australian Research Environment: Ethics, Regulatory and Governance Requirements

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Regulatory

International pharmaceutical and biotechnology companies and research groups can conduct clinical trials in Australia. Trials must, however, be sponsored by an Australian entity. The entity can be an individual, company, institution or organisation that takes responsibility for the initiation, management, provision of insurance and indemnity, and/or financing of a clinical trial. Click here for more information.

Clinical trials conducted using therapeutic goods that have not been registered by the Therapeutics Goods Administration (TGA) for general marketing are required to make use of the Clinical Trial Notification (CTN) or Clinical Trial Exemption (CTX) schemes.

Under a CTN, scientific and ethical review is provided by a human research ethics committee (HREC), with subsequent notification to the TGA. Under a CTX, the TGA reviews the scientific data and must approve; however, HREC review is still required.

Phase I trials do not require an Investigational New Drug (IND) submission, even for the first time in human or proof of concept studies.

The definition of an unapproved therapeutic good encompasses aspects of the product including: formulation, dose form, name, indications, directions for use and container.

“We have a rapid, inexpensive and efficient regulatory scheme.”

regulatory

“Australia has short start-up timelines supported by a central ethics process.”

ethics

Ethics

All clinical trials in Australia require approval by a HREC. HREC’s generally provide both an ethical and scientific review, which may be supplemented on an as-needed basis by external expert advice. Applications to a HREC for approval are usually made using a standardised form. Click here for more information.

Where the Clinical Trials Research Centre acts as a single centre we use the Royal Victorian Eye and Ear Hospital (RVEEH) HREC, which is well experienced with eye research. For Further information on the RVEEH ethics committee: Human Research Ethics Committee.

Good clinical practice

The (TGA) has adopted the European version of note for guidance on good clinical practice (CPMP/ICH/135/95). The TGA advice includes specific comments from the TGA relevant to the Australian context. The TGA has also adopted ISO 14155 Clinical Investigation of medical devices for human subjects – Good clinical practice .

Complementing these guidance documents is Australia’s National Statement on Ethical Conduct in Human Research (2007) – Updated March 2014, published by the NHMRC.

“Our clinical researchers apply adhere to global standards.”

“Agreements and forms are standardised for efficiency.”

Research governance

Site-specific assessment:

  • Public health organisations must undertake a site-specific assessment (SSA) of each research project, allowing the organisation to consider whether the project is suitable for the site. The SSA involves consideration of: physical resources, staff, insurance and indemnity requirements.
  • The SSA and HREC ethical and scientific review may occur in parallel, however the decision to authorise research commencement is only made upon the responsible HREC’s approval and when the SSA has been satisfactorily completed. Applications must be made on the relevant SSA form for that State /Territory.

Clinical Trial Agreements:

  • Standard templates for Clinical Trial Agreements for medicines and devices research and indemnities should be used wherever possible in order to minimise the need for legal review. For medicines research, the templates for contracts and indemnities are maintained by Medicines Australia. For medical device research, these are maintained by Medical Technology Association of Australia.

All trials through the Clinical Trials Research Centre that involve patients from the Eye and Ear Hospital must have the Hospitals’ Governance approval.

Tax incentives


The Incentive provides businesses investing in eligible R&D with generous tax offsets:

  • a 45 per cent refundable R&D tax offset for companies with aggregated annual turnover of less than A$20 million.
  • a 40 per cent non-refundable R&D tax offset for all other eligible companies.

Other benefits include:

  • Clinical trials can be eligible R&D activities under the program and are considered for eligibility under the same rules as any other activity.
  • The Incentive provides for increased access by international companies, i.e, there is no requirement to hold the intellectual property in Australia.
  • Certainty and stability of the rate of support to companies as the rates are no longer linked to the company tax rate.
  • Increased level of expenditure that can be claimed on R&D activities undertaken overseas in support of Australian R&D projects, under certain conditions.

Further information can be found at the Australian Government’s Business website.

“The Australian Government’s generous R&D Tax Incentive encourages more industry investment.”

tax

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